CONtinuous Implantable DOppler Probe Monitoring in Renal Transplantation

NCT05634863 | Completed DMC

• 1 other identifier: 21/SUR/626
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION Vascular complications in kidney transplantation constitute one-third of the early graft loss (EGL) that can be prevented by timely diagnosed cases. A vascular monitoring device may have a possible role in the early identification of graft hypoperfusion critical to reducing graft loss. AIM To evaluate the feasibility of an Implantable Doppler probe as a vascular monitoring device in kidney transplant patients and by obtaining the vital information, inform the protocol development of a definitive RCT. METHODS AND ANALYSIS A mixed-method research design is selected. The quantitative study will comprise a feasibility RCT (fRCT) that will compare demographical characteristics and surgical outcomes of patients that will undergo kidney transplant surgery with vascular monitoring device (intervention group, n=25) against those with standard care clinical observation (control group, n=25). Descriptive statistics will be used to summarise the results that will assess the vascular monitoring capability of implantable Doppler probe in the early postoperative period of kidney transplant patients. The results will provide estimates for surgical outcomes essential to inform the sample size calculation for the definitive study. Information related to the fluency of research methods, availability of research resources, management support, potential challenges faced during the fRCT will be compiled to generate realistic estimates of important parameters for the definitive study. The results will be following the CONSORT updated guidelines for reporting feasibility studies. Qualitative semi-structured interviews of stakeholders (n=12) recruited by purposive sampling will be conducted to explore their experiences of participating in the study, acquire suggestions regarding application of implantable Doppler probe monitoring, and the post implantation patient care. All interviews will be audio-recorded with verbatim transcription. Data will be analysed following the six-phase guide to doing thematic analysis in the NVivo software. The results will be reported in accordance with the consolidated criteria for reporting qualitative research (COREQ) checklist. IMPACT It is anticipated that this study will also elaborate on a possible role of implantable Doppler probe monitoring to improve kidney transplant patient safety, graft survival, service quality improvement, and financial savings in the NHS.

Conditions

Renal Artery Complications; Renal Vein Thrombosis

Keywords

Implantable Doppler probe; Renal vein thrombosis; Renal artery complications

Outcome Measures

Primary Outcomes (4)

• OBJECTIVE 1: To assess the capability of vascular monitoring device in the early postoperative care of kidney transplant patients This objective will be achieved in the feasibility randomised controlled trial.

  OUTCOME MEASURES FOR OBJECTIVE 1: The following outcomes in both the intervention and control groups will be recorded and compared to measure the objective 1. 1. The number of early vascular complications identified in each group (measured as numerical number i.e.,1,2,3 etc). 2. The number of departmental ultrasound scans requested in the first 24, 48, and 72 hours postoperatively in each participant (measured as numerical number i.e.,1,2,3 etc). 3. The number of grafts lost due to vascular complications in each group (measured as numerical number i.e.,1,2,3 etc).

  12 weeks

• OBJECTIVE 2: To assess the research methods used in this feasibility randomised for the definitive planned randomised controlled study This objective will be achieved in the feasibility randomised controlled trial.

  OUTCOME MEASURES FOR OBJECTIVE 2: The suitability of the following research processes used in the study will be estimated. Any difficulties or shortcomings encountered will be highlighted. 1. Difficulties encountered with eligibility criteria and recruitment process (measured as a binary variable i.e., Yes or No). 2. Difficulties encountered with randomisation or allocation concealment (measured as a binary variable i.e., Yes or No). 3. Difficulties encountered with retention/follow-up/compliance of participants (measured as a binary variable i.e., Yes or No). 4. Variation or fidelity encountered in the delivery of the intervention marked against a fidelity checklist (measured as a binary variable i.e., Yes or No)

  12 weeks

• OBJECTIVE 3: To assess the availability of research resources, management support, potential barriers and challenges for the definitive planned future RCT. This objective will be achieved in the feasibility randomised controlled trial.

  OUTCOME MEASURES FOR OBJECTIVE 3: The availability of the following research resources in this study will be recorded. Any shortcomings or non-availability of resources encountered will be highlighted. 1. Availability of participant documentation (i.e., participant information sheet, consent form, data collection sheet) (measured as a binary variable i.e., Yes or No). 2. Availability of medical equipment and healthcare staff in the host centre required to handle the number of participants and the research procedures (measured as a binary variable i.e., Yes or No). 3. Availability of technological capacity for communication and adequate software to randomise, record, process, and store research data (measured as a binary variable i.e., Yes or No). 4. Availability of management support for the research project and back up plans for any extenuating circumstances (measured as a binary variable i.e., Yes or No).

  12 weeks

• Objective 4: To assess the acceptability of the ID probe blood flow monitoring device in clinical practice and get suggestions for the definitive planned future RCT. This objective will be achieved by the embedded qualitative study

  OUTCOME MEASURES FOR OBJECTIVE 4: The acceptability of the intervention in clinical practice will be assessed by conducting the thematic analysis of the views and experiences of stake holders (clinicians, transplant surgeons, nurses, and kidney transplant patients with the experience of receiving/delivering the intervention and participating in the study) obtained by qualitative interviews with open ended questions. Furthermore, suggestions to improve the design of the definitive planned future RCT, functioning of the ID probe blood flow monitoring device, or any aspect of postoperative patient care will also be acquired.

  12 weeks

Study Arms (2)

KIDNEY TRANSPLANT PATIENTS WITH THE IMPLANTABLE CONTINUOUS VASCULAR MONITORING DEVICE

EXPERIMENTAL

The intervention that is intended to be investigated is the implantable vascular monitoring device manufactured by COOK Medical Company. Its principle intended use is continuous monitoring of the graft perfusion (i.e. transplanted kidney) for the first 72 hours postoperatively. The kidney transplant patients in the intervention group will receive implantable continuous vascular monitoring device surveillance for the first 72 hours in addition to the standard care clinical observation as part of their postoperative care. The intervention will be removed after 72 hours postoperatively.

Device: Implantable Doppler probe manufactured by COOK Medical Company.

KIDNEY TRANSPLANT PATIENTS WITH STANDARD CARE CLINICAL OBSERVATION

NO INTERVENTION

The kidney transplant patients in this group will receive the standard care clinical observation as part of their postoperative care. Their graft will be monitored postoperatively by the standard care clinical observation as per the NHS protocol.

Interventions

Implantable Doppler probe manufactured by COOK Medical Company. DEVICE

The continuous audible Doppler signals produced by the monitoring device represent the blood flowing in the renal artery. This is an indicator of graft perfusion. Cessation of audible Doppler signals is the key that may suggest hampered blood flow due to vascular complications. In the intervention group, the monitoring device will be used as an added mechanism to monitor graft perfusion.

KIDNEY TRANSPLANT PATIENTS WITH THE IMPLANTABLE CONTINUOUS VASCULAR MONITORING DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who will have deceased or living kidney donor transplants
• Patients aged 18 years or above.
• Patients able and willing to comply with the trial requirements

You may not qualify if:

• Patients who will have a kidney transplant with more than two arteries (evident at the time of surgery).
• Patients below 18 years of age.
• Patients lacking capacity or unwilling to give consent.

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

University Hospitals Plymouth NHS Trust

Plymouth, Devon, PL3 4RN, United Kingdom

Location

Related Publications (8)

• Schmulder A, Gur E, Zaretski A. Eight-year experience of the Cook-Swartz Doppler in free-flap operations: microsurgical and reexploration results with regard to a wide spectrum of surgeries. Microsurgery. 2011 Jan;31(1):1-6. doi: 10.1002/micr.20816.

  PMID: 20683856 RESULT

• Hakim DN, Nader MA, Sood A, Kandilis A, Hakim NS. Rescue of Transplanted Kidney Thanks to an Implantable Doppler Probe: Is This the Future? Exp Clin Transplant. 2016 Aug;14(4):454-5. doi: 10.6002/ect.2014.0135. Epub 2014 Oct 21.

  PMID: 25343411 RESULT

• Lenz Y, Gross R, Penna V, Bannasch H, Stark GB, Eisenhardt SU. Evaluation of the Implantable Doppler Probe for Free Flap Monitoring in Lower Limb Reconstruction. J Reconstr Microsurg. 2018 Mar;34(3):218-226. doi: 10.1055/s-0037-1608628. Epub 2017 Nov 27.

  PMID: 29179224 RESULT

• Chang TY, Lee YC, Lin YC, Wong ST, Hsueh YY, Kuo YL, Shieh SJ, Lee JW. Implantable Doppler Probes for Postoperatively Monitoring Free Flaps: Efficacy. A Systematic Review and Meta-analysis. Plast Reconstr Surg Glob Open. 2016 Nov 28;4(11):e1099. doi: 10.1097/GOX.0000000000001099. eCollection 2016 Nov.

  PMID: 27975015 RESULT

• Vasant Kulkarni S, Rao PP, Naidu CS, Pathak N, Singh AK. Evaluation of implantable Doppler probe continuous monitoring of hepatic artery anastomosis after liver transplantation. Med J Armed Forces India. 2021 Jul;77(3):349-354. doi: 10.1016/j.mjafi.2020.03.012. Epub 2020 Jun 3.

  PMID: 34305290 RESULT

• Poder TG, Fortier PH. Implantable Doppler in monitoring free flaps: a cost-effectiveness analysis based on a systematic review of the literature. Eur Ann Otorhinolaryngol Head Neck Dis. 2013 Apr;130(2):79-85. doi: 10.1016/j.anorl.2012.07.003. Epub 2012 Nov 23.

  PMID: 23182889 RESULT

• Crane J, Hakim N. The use of an implantable Doppler flow probe in kidney transplantation: first report in the literature. Exp Clin Transplant. 2011 Apr;9(2):118-20.

  PMID: 21453229 RESULT

• de Jong KP, Bekker J, van Laarhoven S, Ploem S, van Rheenen PF, Albers MJ, van der Hilst CS, Groen H. Implantable continuous Doppler monitoring device for detection of hepatic artery thrombosis after liver transplantation. Transplantation. 2012 Nov 15;94(9):958-64. doi: 10.1097/TP.0b013e318269e6ad.

  PMID: 23037006 RESULT

Study Officials

• Robert Fern, PhD

  Peninsula Medical School (Faculty of Health), University of Plymouth

  STUDY DIRECTOR

• M Shahzar Malik, MClinRes

  University Hospitals Plymouth NHS Trust

  PRINCIPAL INVESTIGATOR

• Kris Houlberg, PhD

  University Hospitals Plymouth NHS Trust

  STUDY CHAIR

• Aled Jones, PhD

  Head of School of Nursing and Midwifery, University of Plymouth

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding of the participants (kidney transplant patients) to the outcome of the randomisation will not be possible due to the nature of the intervention. Similarly, the healthcare professionals (clinicians and nurses) taking care of the patients and collecting the data postoperatively cannot be blinded. However, the Southwest transplant team acts in the best interest of the kidney transplant patients and declares no conflict of interest with the device.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention group: kidney transplant patients with the vascular monitoring device): The kidney transplant patients will receive the Implantable continuous vascular monitoring device surveillance for the first 72 hours in addition to the standard care clinical observation as part of their postoperative care. Control group (kidney transplant patients with standard care clinical observation): The kidney transplant patients will receive the standard care clinical observation as part of their postoperative care. The results of the study will be determined by comparing the surgical outcomes in both the intervention and control group.

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: December 2, 2022
• Study Start: April 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)